Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - children and adolescents between the ages of 10-16 years. subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - hba1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - body mass index (bmi) above 85% percentile of the general age and gender matched population exclusion criteria: - type 1 diabetes - maturity onset diabetes of the young (mody) - use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - history of chronic pancreatitis or idiopathic acute pancreatitis - any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - known or suspected abuse of alcohol or drugs/narcotics
gluteal activation with or without traction straight leg raise technique

Conditions: SIJ - Sprain of Sacroiliac Joint; Weakness, Muscle; Tightness of Back Muscles

Summary: this study was a randomized clinical trial conducted to determine the effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is important in low back pain or sacroiliac joint syndrome, and how it affects our sling system.

non probability convenient sampling was done . patients following eligibility criteria from sports and spine professionals ,lahore were considered. sample size was calculated with epi tool calculator. 38 participants were randomly allocated in two groups equally via convenient sampling method. baseline assessment was done initially. group a was given gluteal activation exercises with traction straight leg raise technique for hamstring and group b was gluteal activation exercises without traction straight leg raise technique for hamstring. duration of research was almost 6 months. patient will undergo 10 treatments in five weeks. each session will take 30 minutes. pre and post treatment readings were taken in 1st and 10th session over a 5 week period respectively. assessment was done via sphygmomanometer and numeric pain rating scale for assessing muscle strength of gluteus maximum and pain levels respectively. all participants were provided written informed consent prior to commencement of the procedures. they were free to quit the treatment at any stage of research. data was analyzed by using spss version 23.

Eligibility criteria:
inclusion criteria: 1. subjects with lbp below the level of l5, 2. with pain over the posterior aspect of si joint around posterior superior iliac spine and buttock with or without above knee leg pain. 3. females only exclusion criteria: 1. had radicular pain with neurological (sensory or motor) deficits, 2. had a history of spinal surgery, spinal, pelvic, or lower extremity fracture; hospitalization for trauma or motor vehicle accident; 3. hip or knee dysfunctions; 4. pregnancy; 5. any systemic disease such as arthritis, tuberculosis, liver, or kidney failure 6. subjects with leg length discrepancies, because of its potential effect on hamstring muscle length were also excluded. -

Keywords: gluteal activation straight leg raise hamstring technique sacroiliac joint pain
post market clinical follow-up study of irisfittm pfo (patent foramen ovale) occluder

Conditions: Patent Foramen Ovale

Summary: the purpose of the study is to collect more data about performance and safety of the device called "irisfittm pfo occluder". this data will be used to help more patients who will accept treatment with this device in the future. patients will undergo routine examination, procedure and follow-up. related data will be collected and kept in a way that patient info is well protected.

this is a post market clinical follow-up study. informed consent will be obtained from the patient or from a legally authorized representative of the patient at screening. the patients will be screened (pre-procedure) to determine eligibility for the study. at screening, patients will be assessed for study eligibility by the inclusion/exclusion criteria through their medical history, demographics and transthoracic echocardiography (tte). participating patients will have their pfo closed using the irisfittm pfo occluder device. the patients will undergo a clinical examination, electrocardiogram (ecg), clinical laboratory assessment and transthoracic echocardiography (tte). all periprocedural procedures will be performed according to site´s standard of care.. the efficacy and safety of the devices will be assessed by ecgs, vital signs, physical examination and tte, which will be done at 1day, at 1month and at 6 months post procedure. safety will also be assessed at 12 months by telephone visit.

Eligibility criteria:
inclusion criteria: * patients who are according to current international or local guidelines (and future revisions) and per physician discretion scheduled for interventional treatment of pfo. * patients who are willing and capable of providing informed consent and participating in all testing/or follow procedure associated with this study. * patients who are eligible for treatment with irisfit pfo occluder device. (per physician discretion and device ifu). exclusion criteria: * pfo tunnel length \<1 mm * women of childbearing potential who are or plan to become pregnant during the time of the study (method of assessment upon physician's discretion) * patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

Keywords: irisfit pfo
metformin add-on study in patients with type 2 diabetes mellitus (0431-020)(completed)

Conditions: Diabetes Mellitus, Type II

Summary: the purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus

Keywords: type 2 diabetes mellitus
effectiveness of neurodynamic sliding mobilisation in the "slump" position in relation to the perceptible pain threshold in asymptomatic people

Conditions: Voluntary

Summary: according to the french national health agency, the use of manual therapy techniques is "possible" \[grade b\] as part of a multimodal combination of treatments for low back pain. these include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. pain reduction is observed in more areas of the body with sliding techniques than with traction techniques. in this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes


Eligibility criteria:
inclusion criteria: subjects aged 30 years or older and less than 65 years; * subjects considered naive to neurodynamic mobilisation techniques; * volunteers who have read and understood the information letter and have given their written consent to participate in the study; * fluent in spoken and read french; * effective contraception in women of childbearing age (progestin-only or intrauterine device or tubal ligation) for at least 12 months; * for postmenopausal women, a confirmatory diagnosis must be obtained (non-drug-induced amenorrhoea for at least 12 months prior to the enrolment visit); * subject affiliated to a social security scheme. exclusion criteria: * positive slump test on the day of the selection visit (production of asymmetric lumbar symptoms or painful radiations in at least one lower limb or unilateral reduction in physiological knee extension range of motion compared with the contralateral side); * neurological and neuropathic pain assessment score (dn4) greater than 4; * increase or decrease in sensory function in the lower limb compared with the contralateral side, as measured by clinical sensory testing (cst); * any physical exertion of perceived intensity greater than 17 on the borg 6-20 scale in the 72 hours prior to the trial and during the trial; * injury, complaint or symptom affecting the spine (cervical, thoracic, lumbar) and/or lower limb(s) requiring absence from work, school or leisure activities in the 12 months prior to enrolment; * history of major surgery, injury to the trunk, spine and/or lower limb(s), or history of progressive rheumatic, neurological or oncological pathology;
ultrasound guided lateral sphincterotomy: long term results

Conditions: Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Summary: ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. secondly 3-d ultrasound visualizes that the internal anal sphincter is divided.


Eligibility criteria:
inclusion criteria: patients undergoing lateral sphincterotomy for chronic anal fissure exclusion criteria: * previous diltiazem treatment og botox injections were not performed
dose-effect of ssr180575 in diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: the primary objective of this sudy is to assess the effect of two doses of ssr180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. secondary objectives are to explore the efficacy of ssr180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of ssr180575. the treatment period is 6 months.


Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetes mellitus, type i or ii, treated or untreated * diabetic neuropathy treated or untreated exclusion criteria: * patients with unstable glycemic control * patients who have been hospitalized for a diabetes complication in the 3 months prior to randomization * patients with peripheral neuropathy attributable to any cause other than diabetes * non-measurable sural nerve sensory response on nerve conduction studies * amputation of any part of lower extremity * patients with a history of myocardial infarction or known coronary artery disease * grade iii or iv heart failure on new york heart association criteria the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: diabetes neuropathy
inspiratory muscle training, autonomic dysfunction and blood pressure

Conditions: Hypertension

Summary: this study finds the effectiveness of inspiratory muscle threshold loading training among adults with hypertension. a sample of hypertensive subjects was divided into two groups - inspiratory muscle training (imt) - group (inspiratory muscle training was prescribed) and sham-group (no load was prescribed during imt). both groups had training sessions comprising seven cycles of two minutes bouts of breathing counter to an inspiratory load, each bout parted by one minute of unloaded recovery. treatment session was performed for three times per week for a total of six weeks. measurement of each of the variables (blood pressure, resting heart rate (rhr), heart rate variability (hrv)) was taken at baseline and after the six-week intervention.

the present study aimed to examine the outcome of interval inspiratory muscle training at 70% load on blood pressure, resting heart rate and autonomic dysfunction in the hypertensive adults. participants were divided into two groups: imt and sham. in imt group, the threshold loading inspiratory muscle trainer from powerbreathe was used with 70% imt threshold. in sham group, imt was unloaded.

Eligibility criteria:
inclusion criteria: * stage 1 hypertension * essential hypertension * mild hypertension exclusion criteria: * subjects participating in exercise training for more than the last six months * severe musculoskeletal limitations * severe neurological limitations * cognitive impairments * uncontrolled diabetes * uncontrolled hypertension * a history of myocardial infarction (mi) * a history of stroke in the last six months * unstable angina * chronic heart failure * pulmonary disease of any etiology

Keywords: interval inspiratory muscle training hypertension autonomic dysfunction blood pressure
comparative results of maxillary deficiency treatment by tongue plate and facemask in growing patients

Conditions: Maxillary Deficiency

Summary: a new appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask appliance.

the above method will be compared with traditional one which uses the facemask in combination with an intra-oral appliance.

Eligibility criteria:
inclusion criteria: * growing patients * class iii with maxillary deficiency exclusion criteria: * previous orthodontic treatment * un cooperative patients

Keywords: tongue plate facemask class iii maxillary deficiency orthodontic angle class three
efficacy and safety of an ire system for treatment of inferior turbinate hypertrophy

Conditions: Inferior Turbinate Hypertrophy; Nasal Obstruction; Turbinate; Hypertrophy Mucous Membrane

Summary: the purpose of the ire system is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. procedure time will also be reduced. the ire system is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the inferior turbinate volume.

the purpose of the ire system is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. procedure time will also be reduced. the ire system is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume. on basis of these finding and in view of the known safety profile (refer to chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the ire system in interior turbinate reduction.

Eligibility criteria:
inclusion criteria: * age 18 - 70 years. * nasal obstruction symptom evaluation (nose) score of ≥ 60 at the baseline. * hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test. * did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months. exclusion criteria: * age below 18 years * patients with a pacemaker or similar electro stimulator * patients with caudal septal deviation that narrows the anterior nasal valve. * patients with nasal polyps/tumors. * patients with chronic rhinosinusitis. * patients with eosinophilia * patients for whom the anesthesia involves high risk. * patients with epilepsy or other condition involving convulsions. * patients with an inability to give informed consent and to complete self-reported questionnaires. * patients with an inability to cooperate for treatment and follow-up. * patients with severe heart disease. * pregnancy or breastfeeding. * previous inferior turbinate surgery.
improving outcomes of necrotising otitis externa

Conditions: Necrotising Otitis Externa

Summary: a uk multi-centre prospective observational study of clinically possible cases of noe.

patients with clinically possible noe for whom ct imaging is requested will be recruited to the study by hospital staff at 20-25 uk sites. noe remains a relatively uncommon condition with uk - ent surgeons report seeing between 1 and 10 cases per year. we plan to recruit 350 patients consented prior to or after ct imaging for a diagnosis of clinically possible noe. after providing consent, patients will be asked to complete an eq-5d-3l questionnaire. for patients consented remotely, this questionnaire will be completed via an interview. local study staff will complete an online case report form hosted on redcap™ for each patient including data on demographics, co-morbidities, clinical presentation, investigations and surgical and antibiotic management. local study staff will review patients' hospital notes and contact patients' gps by telephone 1-year post recruitment to assess clinical outcomes and mortality rates. patients will then be contacted 12 months (+/- 1 month) post-recruitment by telephone by local study staff in order to confirm clinical outcomes (e.g. relapse) and gain information to complete the eq-5d-3l questionnaire a second time. all ct scans performed at recruitment and any other ct and/or mri scans performed in the 12-month follow-up period will be de-identified and uploaded by local sites to an online, web-based secure repository for radiological images. subspecialised radiologists blinded to clinical details will assess the images according to pre-agreed, standardised criteria. selected sites will be asked to freeze any p. aeruginosa isolates routinely collected via ear swabs as part of clinical care from enrolled participants within 14 days of ct imaging. these de-identified samples may be sent from sites to undergo genotypic and phenotypic analysis at the university of oxford for virulence factors to assess the relationship between these and disease severity. of note, no samples beyond those routinely collected as part of the patients' care will be collected and no patient tissue samples will be stored. these samples will not contain any biological or genetic material from the patient.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old). * clinical diagnosis of possible noe for whom ct imaging is requested or has been done as part of routine clinical care. exclusion criteria: * any previous clinical diagnosis of noe. * ct performed or due to be performed at hospital other than recruiting study site.

Keywords: infection antimicrobials otitis externa
safety, tolerability, and pharmacokinetics of amg 827 in adolescents with asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.


Eligibility criteria:
inclusion criteria: * male and/or female subjects 12 to \< 18 years of age at the time of randomization * male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization * body weight ≥ 36 kg at screening * intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 global initiative for asthma \[gina\] guidelines. exclusion criteria: * experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment. * hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma. * use of oral corticosteroids within 3 months prior to study enrollment.

Keywords: amgen adolescent single dose safety pharmacokinetics
mechanisms of glucose counterregulation in pancreatic islet transplantation

Conditions: Type 1 Diabetes Mellitus

Summary: pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. however, the extent and underlying metabolic pathways of this improvement are unknown. investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.

subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.

Eligibility criteria:
t1dm/itx+ inclusion criteria: * type 1 diabetes * pancreatic islet transplantation exclusion criteria: * type 2 diabetes

Keywords: type 1 diabetes mellitus hypoglycemia counterregulation, pancreatic islet transplantation